The Project Coordinator for the PRMC and DSMC is responsible for assisting in the operational oversight of the Protocol Review and Monitoring Committee (PRMC) and the Data Safety and Monitoring Committee (DSMC) in accordance with guidelines set forth by CCSG, the Food and Drug Administration, as well as the Columbia University Institutional Review Board policies and procedures mandated for compliance in clinical trials involving human subject clinical research. The candidate interacts with staff members to facilitate compliance in the administrative and regulatory conduct of human subjects' clinical trials conducted by Principal Investigators in the Herbert Irving Comprehensive Cancer Center (HICCC). The incumbent serves as a conduit of protocol information to departmental faculty, clinical, and research staff. This position reports directly to the Senior Quality and Safety Manager.
Responsibilities include, but are not limited to:
Coordinates bi-monthly Protocol Review and Monitoring Committee (PRMC) meetings and Data and Safety Monitoring Committee (DSMC) meetings
Creates and disseminates meeting agendas including meeting packets.
Prepares complete accurate minutes of the meeting including attendance, actions taken, the vote on these actions, the basis for requiring changes in research, and a written summary of and their resolution.
Prepares written correspondence to investigators of applicable DSMC/PRMC actions and decisions.
Manages collection and distribution of reports.
Collaborates with the Chair of the DSMC to oversee the assignment of new trials.
Collaborates with the Chair of the PRMC to assign reviewers to studies.
Manages the PRMC inbox and all correspondences with PIs regarding protocol approvals, amendments, and stipulations.
Executes decisions regarding expedited approval and studies needing administrative approval.
Tracks low accruing trials and are responsible for knowledge regarding trial accrual history and presenting these findings to the PRMC.
Oversees all bi-monthly PRMC meetings, documentation of reviewer comments distributes decision emails and monitors the progression of trials in need of revision.
Provides guidance on issues related to DSMC/PRMC regulations and actions.
Maintains electronic files and all other required regulatory documents in compliance with federal regulations, institutional policies, and SOPs.
Assists in the training of all new PRMC/DSMC members on review processes.
Interacts with Velos Data Specialists to provide and track all administrative and regulatory information on human subject's clinical research trials from activation to termination of the projects.
Participates in the creation of standard operating policies and procedures.
Create and analyze efficiency metrics for the PRMC and DSMC Chairs, as well as HICCC Executive Leadership. Provide applicable data and reports for HICCC grant renewals. Liaise with HICCC Shared Resources as needed to cultivate and maintain productive working relationships.
Other duties as assigned.
Bachelor's degree or equivalent in education, training, and experience plus 3 years of related, clinical research experience.
Extensive knowledge of GCP, FDA, and DHHS policies
Experience with paper Case Report Forms (CRFs) and/or electronic research databases
Knowledge of medical terminology and procedures specifically related to oncology
Experience with Human Subjects clinical research QA/monitoring processes and audit procedures.
Excellent interpersonal and organizational skills
Ability to take initiative and work independently
Computer Skills: proficiency with MS Word programs and familiarity with Mac and PC platforms
Equal Opportunity Employer / Disability / Veteran
Columbia University is committed to the hiring of qualified local residents.
Internal Number: 513505
About Columbia University
Columbia University is one of the world's most important centers of research and at the same time a distinctive and distinguished learning environment for undergraduates and graduate students in many scholarly and professional fields. The University recognizes the importance of its location in New York City and seeks to link its research and teaching to the vast resources of a great metropolis. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.